Date Initiated by Firm |
November 16, 2007 |
Date Posted |
March 05, 2008 |
Recall Status1 |
Terminated 3 on March 26, 2008 |
Recall Number |
Z-0573-2008 |
Recall Event ID |
45881 |
510(K)Number |
K052141
|
Product Classification |
Electrosurgical Suction Tip - Product Code GEI
|
Product |
Stryker Disposable StrykeProbe 32cm L- Tip, Ref: 250-070-550, Electrosurgical Suction Tip, Stryker Endoscopy, San Jose, CA 95138. |
Code Information |
Lot Number: 07297FE2 |
Recalling Firm/ Manufacturer |
Stryker Endoscopy 5900 Optical Ct San Jose CA 95138
|
For Additional Information Contact |
408-754-2124
|
Manufacturer Reason for Recall |
Cannot connect: Tips have electrodes that are too large to fit monopolar cables and are unusable.
|
FDA Determined Cause 2 |
Device Design |
Action |
Stryker notified their sales representatives by phone. Stryker sent all consignees a Product Advisory Notice dated November 19, 2007, and verbally notified them of the recall via telephone. A response form with return postage was sent with the notice. The letter requested the hospitals to quarantine and return the product to Stryker. |
Quantity in Commerce |
59 boxes of 6 units (354 total) |
Distribution |
Nationwide Distribution. |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = GEI and Original Applicant = Stryker Endoscopy
|